Tegileridine vs Sufentanil for Postoperative Pain Management and Gastrointestinal Recovery After Major Laparoscopic Abdominal Surgery

Phase 4Not Yet RecruitingNCT07637968

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine84 enrolled

Overview

This study is a single-center, randomized, triple-blind clinical trial designed to compare tegileridine and sufentanil for postoperative analgesia and gastrointestinal tolerability in patients undergoing major laparoscopic abdominal surgery. Participants will be randomly assigned to receive either tegileridine or sufentanil for postoperative patient-controlled intravenous analgesia according to the study protocol. The purpose of this study is to determine whether tegileridine can provide better gastrointestinal tolerability while maintaining non-inferior postoperative pain control compared with sufentanil in this patient population.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Postoperative Pain

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18-75 years. * Elective major abdominal surgery as defined above. * Body mass index (BMI) 18-30 kg/m². * American Society of Anesthesiologists (ASA) physical status I to III. * Written informed consent. Exclusion Criteria: * Known hypersensitivity to opioids or any component of the study medications. * Clinically significant hypoxemia, such as oxygen saturation less than 90 percentage, or a history of severe asthma. * Known or suspected gastrointestinal obstruction, including paralytic ileus. * Pregnancy or breastfeeding. * Severe hepatic impairment (Child-Pugh class C). * Severe heart failure (NYHA class III-IV) or unstable arrhythmia. * Neurological or psychiatric disorders that may interfere with pain or sedation assessment (e.g., epilepsy, impaired consciousness, uncontrolled psychiatric illness). * History of chronic pain or long-term use of analgesics/analgesic products. * Current use of sedative-hypnotic medications.

Outcomes

Primary Outcomes

Area Under the Curve of Resting Pain Intensity Within 24 Hours After Admission to the PACU

The cumulative resting pain score within 24 hours after admission to the post-anesthesia care unit (PACU) will be represented by the area under the curve of the numeric rating scale (NRS) scores from 0 to 24 hours. Resting pain intensity will be assessed using an 11-point NRS, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. NRS scores will be measured at 0, 6, 12, 18, and 24 hours after admission to the PACU.

Time frame: From 0 to 24 hours after admission to the PACU

Secondary Outcomes

Resting and Movement Pain Intensity

Resting and movement pain intensity will be assessed using an 11-point NRS, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. NRS scores will be recorded at 0, 0.5, 6, 12, 18, 24, 48, and 72 hours after admission to the PACU.

Time frame: At 0, 0.5, 6, 12, 18, 24, 48, and 72 hours after admission to the PACU

PCIA Demand and Effective Press Counts

Total PCIA demand counts and effective press counts recorded within 48 hours after admission to the PACU.

Time frame: Within 48 hours after admission to the PACU.

Use of Rescue Analgesia

The dose and frequency of rescue analgesic medications, including additional opioid analgesics, will be recorded within 72 hours after admission to the PACU.

Time frame: Within 72 hours after admission to the PACU

Incidence and Severity of PONV

The incidence and severity of postoperative nausea and vomiting (PONV) will be assessed using a standardized nausea and vomiting assessment scale within 72 hours after admission to the PACU.

Time frame: Within 72 hours after admission to the PACU

Time to First Flatus

Time to first flatus will be defined as the time from admission to the PACU to the first passage of flatus.

Time frame: From admission to the PACU until first passage of flatus, assessed up to 1 week.

Time to First Bowel Movement

Time to first bowel movement will be defined as the time from admission to the PACU to the first postoperative bowel movement.

Time frame: From admission to the PACU until first bowel movement, assessed up to 1 week.

Time to Resumption of Oral Intake

Time to resumption of oral intake will be defined as the time from admission to the PACU to the first postoperative intake of liquids, semi-liquid food, or regular diet.

Time frame: From admission to the PACU until resumption of oral intake, assessed up to 1 week.

Length of Postoperative Hospital Stay

Length of postoperative hospital stay will be defined as the number of days from the day of surgery to hospital discharge.

Time frame: From admission to the PACU until hospital discharge, assessed up to 30 days.